IDMP in Pharma Explained
What is IDMP in pharma?
IDMP (Identification of Medicinal Products) is a set of ISO standards that define standard data elements and definitions for identifying and describing human medicinal products. Using the same definitions everywhere lets regulators, companies and healthcare systems exchange product information reliably. In EMA's words, the standards "specify the use of standardised definitions for the identification and description of medicinal products for human use." The aim is to "facilitate the reliable exchange of medicinal product information in a robust and consistent manner" and support "interoperability across global regulatory and healthcare communities" (EMA ISO IDMP overview).
Approach: EU Directive 2001/83/EC and ICH M4 (CTD) contain no IDMP-specific text, so this answer comes from EMA's official ISO IDMP and SPOR pages.
The five ISO IDMP standards (EMA):
| Standard | Covers |
|---|---|
| ISO 11238 | Substances |
| ISO 11239 | Pharmaceutical dose forms, units of presentation, routes of administration, packaging |
| ISO 11240 | Units of measurement |
| ISO 11616 | Regulated pharmaceutical product information |
| ISO 11615 | Regulated medicinal product information |
Legal basis in the EU: EMA cites Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012. These require Member States, marketing authorisation holders and EMA to use the ISO IDMP standards (EMA; Regulation 520/2012, OJ L 159).
How EMA is putting it in place (SPOR): EMA is introducing IDMP in phases, organised around four types of master data: substance, product, organisation and referential (EMA SPOR page).
- Organisations Management Service (OMS): organisation names and location addresses for marketing authorisation holders, sponsors, regulators and manufacturers. It is already running and feeds the electronic application forms for initial authorisations, variations and renewals, for both human and veterinary medicines.
- Referentials Management Service (RMS): controlled vocabularies, such as dosage forms, units of measurement and routes of administration. It is already running.
- Substance Management Service (SMS): data to uniquely identify the ingredients and materials in a product. EMA places it in the second phase, which is still being developed.
- Product Management Service (PMS): data to uniquely identify a human medicine from its regulated information (marketing authorisation, packaging, medicinal information). Also second phase; EMA is consulting stakeholders on using it for regulatory submissions.
What it means for marketing authorisation holders now: Submitting data on authorised medicines under Article 57 has been mandatory since July 2012. The current format, xEVPRM, "will be replaced by the ISO IDMP compatible format" (EMA). The ISO IDMP standards apply to human medicines, but EMA states that SPOR covers both human and veterinary medicines.
EMA publishes the detailed submission rules in its EU IDMP Implementation Guide, for example the PMS Chapter 1 registration requirements. I didn't open those chapters for this answer, so this summary doesn't cover their field-level or timeline details. I can go through them, or look into how the FDA or other authorities apply IDMP, if that would help.
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